Trial Outcomes & Findings for Suitability of DCE-MRI for Detection of Vascular Changes After VBT (NCT NCT01991808)
NCT ID: NCT01991808
Last Updated: 2019-11-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
2 years
Results posted on
2019-11-26
Participant Flow
Participant milestones
| Measure |
DCE-MRI
Radiotherapy and dynamic contrast enhanced magnetic resonance imaging
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suitability of DCE-MRI for Detection of Vascular Changes After VBT
Baseline characteristics by cohort
| Measure |
DCE-MRI
n=16 Participants
Radiotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
DCE-MRI
n=16 Participants
Radiotherapy
|
|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
Adverse Events
DCE-MRI
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DCE-MRI
n=16 participants at risk
Radiotherapy
|
|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
12.5%
2/16
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 5
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection, Pelvis NOS
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Urethral pain
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
4/16 • Number of events 4
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal pain
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place